Pharmacokinetic Study of a Fixed Dose Combination Nefopam Hydrochloride (30 mg) / Paracetamol (500 mg) (ARL/20/277)

Pharmacokinetic Study of a Fixed Dose Combination Nefopam Hydrochloride (30 mg) / Paracetamol (500 mg) and Individual Nefopam Hydrochloride and Paracetamol Taken Alone or Concomitantly After Oral Single Dose

This study aims to assess the pharmacokinetic profile of a Fixed Dose Combination nefopam hydrochloride (30 mg) / paracetamol (500 mg) and individual components taken alone or concomitantly after oral single dose.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2; Drug: nefopam hydrochloride 30mg X2; Drug: paracetamol 500 mg X2

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Navi Mumbai, India, 400709
    • Accutest Research Laboratories

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male and non-pregnant female human subjects, age 18 - 45 years.
• Body Mass Index between 18.5-30 Kg / m2 .
• Subjects with normal findings .
• Willingness to follow the protocol requirements

Exclusion Criteria:

• Known history of hypersensitivity to Nefopam, Paracetamol or related drugs.
• Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
• Subjects with a history of convulsive disorders.
• Subject with a moderate or severe renal impairment
• History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
• Female subjects not confirming to using birth control measures,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FDC nefopam hydrochloride 30mg / paracetamol 500mg; Single dose: 2 tablets	Drug: Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2; Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2
Active Comparator: nefopam hydrochloride 30mg; Single dose: 2 tablets	Drug: nefopam hydrochloride 30mg X2; nefopam hydrochloride 30mg X2
Active Comparator: paracetamol 500mg; Single dose: 2 tablets	Drug: paracetamol 500 mg X2; paracetamol 500 mg X2; Other Names: acetaminophen
Active Comparator: nefopam hydrochloride 30mg and paracetamol 500mg; Single dose: 2 tablets	Drug: nefopam hydrochloride 30mg X2; nefopam hydrochloride 30mg X2; Drug: paracetamol 500 mg X2; paracetamol 500 mg X2; Other Names: acetaminophen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nefopam and Paracetamol Pharmacokinetic Profiles in Each Arms After Single Dose	Peak Plasma Concentration (Cmax) of nefopam hydrochloride and paracetamol after single dose at different timepoints : Within 60 min before drug administration),0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours	up to 48 hours post dose
Nefopam and Paracetamol Pharmacokinetic Profiles in Each Arms After Single Dose	Area under the plasma concentration versus time curve (AUC) of nefopam hydrochloride and paracetamol after single dose at different timepoints : Within 60 min before drug administration),0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours	up to 48 hours post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Occurrence and severity of adverse events (serious and non-serious adverse events)	Up to 48 hours
Paracetamol Metabolites Pharmacokinetic Profiles in Each Arms After Single Dose	Peak Plasma Concentration (Cmax) of main paracetamol metabolites (Sulfate and Glucuronide) after single dose at different timepoints : Within 60 min before drug administration),0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours	up to 48 hours post dose
Paracetamol Metabolites Pharmacokinetic Profiles in Each Arms After Single Dose	Area under the plasma concentration versus time curve (AUC) of main paracetamol metabolites (Sulfate and Glucuronide) after single dose at different timepoints : Within 60 min before drug administration),0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours	up to 48 hours post dose
N-desmethyl-nefopam Pharmacokinetic Profiles in Each Arms After Single Dose	Peak Plasma Concentration (Cmax) of N-desmethyl-nefopam after single dose at different timepoints : Within 60 min before drug administration),0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours	up to 48 hours post dose
N-desmethyl-nefopam Pharmacokinetic Profiles in Each Arms After Single Dose	Area under the plasma concentration versus time curve (AUC) of N-desmethyl-nefopam after single dose at different timepoints : Within 60 min before drug administration),0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours	up to 48 hours post dose

Collaborators and Investigators

• Sponsor: Unither Pharmaceuticals, France
• Collaborators: Accutest Research Laboratories (I) Pvt. Ltd.
• Investigators: Principal Investigator: Pramila Yadav, MS, Accutest Research Laboratories

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2021
• Primary Completion (Actual): December 27, 2021
• Study Completion (Actual): December 27, 2021

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Acetaminophen; Nefopam
• Other Study ID Numbers: UP-CLI-2019-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No